Percent change in weight from Baseline to Week 12 will be assessed as the primary outcome measure. Subjects will be asked to step on a special scale called a TANITA which will calculate weight, fat mass at each study visit.

Efficacy measures including the Brief Psychiatric Rating Scale (BPRS-C) which measures symptomatology on five subscales including depression/anxiety, psychomotor excitation/mania, behavior problems, thinking disturbance, and organicity and the Aberrant Behavior Checklist-Community (ABC-C) which focuses on problem behaviors in five subdomains, including irritability, attention, repetitive behaviors, unusual speech, and social withdrawal.

Overall psychiatric functioning will be assessed with the severity (CGI-S) and improvement (CGI-I) subscales of the CGI. CGI-S items are rated from 1 (normal, not ill) to 7 (very severely ill). CGI-I items are rated from 1 (very much improved) to 7 (very much worse).

This is a multi-site, 12-week, open-label study assessing the weight and metabolic changes associated with lurasidone treatment. Antipsychotic naive subjects will start open-label treatment by following a flexible titration schedule. Quasi-antipsychotic naive subjects (less than 4 weeks of total AP treatment) will be started on lurasidone and tapered off the other antipsychotic over an estimated 4 weeks depending on the dose and tolerability of the prior antipsychotic. Other psychoactive medications including antidepressants, benzodiazepines, stimulants, alpha-2 agonists, and mood stabilizers are allowed as long as the dose is not changed, unless it is clinically necessary. Assessments of weight, efficacy, and side effects are conducted at baseline, week 2, week 4, week 8, and week 12. The primary outcome is percent change in weight. The secondary outcomes include psychiatric efficacy measures and side effects.

Eligibility

Ages Eligible for Study:

6 Years to 19 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male and female children and adolescents between 6 and 19 years of age of any race or ethnicity

Subject must meet DSM-IV-TR criteria for a psychotic spectrum, mood spectrum or autism spectrum disorder as defined by one of the following diagnoses:

schizophrenia (any type)

schizoaffective disorder

schizophreniform disorder

psychosis NOS

autistic disorder with significant irritability/aggression (ABC-C Irritability subscale score of greater than or equal to 18)

Asperger syndrome with significant irritability/aggression (ABC-C Irritability subscale score of greater than or equal to 18)

Ongoing or previously undisclosed child abuse requiring new department of social service intervention

Subjects who, in the Investigator's opinion, might not be suitable for the study

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731119

Locations

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21205

University of Maryland

Baltimore, Maryland, United States, 21205

United States, New York

The Zucker Hillside Hospital

Glen Oaks, New York, United States, 11004

United States, North Carolina

University of North Carolina

Chapel Hill, North Carolina, United States, 27517

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Foundation of Hope, North Carolina

Johns Hopkins University

University of Maryland

The Zucker Hillside Hospital

Investigators

Principal Investigator:

Linmarie Sikich, MD

University of North Carolina, Chapel Hill

Principal Investigator:

Mark Riddle, MD

Johns Hopkins University

Principal Investigator:

Christoph Correll, MD

The Zucker Hillside Hospital

Principal Investigator:

Gloria Reeves, MD

University of Maryland

More Information

No publications provided

Responsible Party:

Linmarie Sikich, MD, Associate Professor of Psychiatry, University of North Carolina, Chapel Hill